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Clinical Trials in China / NCT06943781
Recruiting Observational

Prospective Gastric Cancer Screening Using Helicobacter Pylori High-Risk Single Nucleotide Polymorphism Detection

NCT06943781 · tracked via the Priya Life Science China tracker
Sponsor
Fudan University
Phase
Observational
Started
2025-07-01
Last updated
2026-02-25

Condition(s) studied

Gastric AdenocarcinomaHelicobacter Pylori

Investigational drug(s) / intervention(s)

Fecal Helicobacter pylori gastric cancer susceptibility gene test

Fecal Helicobacter pylori gastric cancer susceptibility gene test: In the early stage of the study, the team used genome-wide association analysis (GWAS) to identify H. pylori specific SNP that are significantly associated with gastric cancer in gastric cancer patients and controls; according to the mutation or not of the SNP loci, the strains were categorized into the high-risk group of gastric cancer and the low-risk group. The status of the SNP locus was detected in portable and non-invasive fecal samples from participants using molecular biology assays for early non-invasive screening and risk assessment of gastric cancer in H. pylori infected patients.

Study summary

This is a prospective study designed to compare the performance of fecal H. pylori gastric cancer susceptibility analysis and the gastric cancer risk questionnaire for the early detection of gastric cancer. The primary objective is to assess whether each method, individually or in combination, can facilitate earlier diagnosis of gastric cancer. All participants will undergo fecal H. pylori gastric cancer susceptibility testing and complete the gastric cancer risk questionnaire.

Eligibility

Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 1. Age ≥40 years, male or female. 2. No contraindications to endoscopy and able to cooperate with endoscopy. 3. Patients must be able to fully understand the informed consent form and be able to sign the informed consent form in person. Exclusion Criteria: 1. A history of diagnosed gastric cancer or other malignant tumors of the digestive tract. 2. Comorbid severe underlying conditions (e.g., severe cardiopulmonary insufficiency, liver or renal failure, etc.) that are likely to result in a short life expectancy or render long-term follow-up impractical. 3. Severe mental illness or incapacity to participate in the study due to lack of civil behavior. 4. Pregnant or breastfeeding women. 5. Other conditions that the investigator deems inappropriate for participation in the study.

Primary outcome measure(s)

  • Sensitivity and specificity of fecal H. pylori gastric cancer susceptibility testing and questionnaire for gastric cancer — 2 years
    To compare the sensitivity and specificity of fecal H. pylori gastric cancer susceptibility testing and questionnaire screening for gastric cancer.

Trial sites (1)

FacilityCityRegionStatus
People's Hospital of Tongling City Tongling China Recruiting

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Other trials for the same condition

Retlirafusp Alfa Combined With Apatinib and Nab-Paclitaxel as Second-line Treatment for Gastric or Gastroesophageal Junction Cancer Starting soon
Defining Benchmarks for Gastric Cancer Patients Underwent Minimal Invasive Gastrectomy Active, not recruiting
Sino-Russian Comparison of Outcomes After Proximal Gastrectomy With Double-Tract Reconstruction Starting soon
Iparomlimab and Tuvonralimab Injection (QL1706) Combined With DOS as Neoadjuvant Therapy for Locally Advanced Adenocarcinoma of the Stomach and Gastroesophageal Junction Active, not recruiting
Fruquintinib Combined With Trastuzumab and XELOX as First-line Treatment in Patients With HER2-positive Advanced Gastric Cancer Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06943781 on ClinicalTrials.gov ↗ ← All trials in China